Notice2021-23741
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
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Published
November 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.
Full Text
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<title>Federal Register, Volume 86 Issue 208 (Monday, November 1, 2021)</title>
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[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60258-60259]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23741]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4130]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping Requirements for Microbiological Testing
and Corrective Measures for Bottled Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the procedure by which both
domestic and foreign bottled water manufacturers that sell bottled
water in the United States maintain records of microbiological testing
and corrective measures, in addition to existing recordkeeping
requirements.
DATES: Submit either electronic or written comments on the collection
of information by January 3, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 3, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-4130 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping Requirements for
Microbiological Testing and Corrective Measures for Bottled Water.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management
[[Page 60259]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#a6f6f4e7f5d2c7c0c0e6c0c2c788ceced588c1c9d0"><span class="__cf_email__" data-cfemail="722220332106131414321416135c1a1a015c151d04">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Recordkeeping Requirements for Microbiological Testing and Corrective
Measures for Bottled Water--21 CFR 129.35(a)(3)(i), 129.80(g), and
129.80(h)
OMB Control Number 0910-0658--Extension
The bottled water regulations in parts 129 and 165 (21 CFR parts
129 and 165) require that if any coliform organisms are detected in
weekly total coliform testing of finished bottled water, followup
testing must be conducted to determine whether any of the coliform
organisms are Escherichia coli (E. coli). The adulteration provision of
the bottled water standard (Sec. 165.110(d)) (21 CFR 165.110(d))
provides that a finished product that tests positive for E. coli will
be deemed adulterated under section 402(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)). In addition, the current
good manufacturing practice (CGMP) regulations for bottled water in
part 129 require that source water from other than a public water
system be tested at least weekly for total coliform. If any coliform
organisms are detected in the source water, bottled water manufacturers
are required to determine whether any of the coliform organisms are E.
coli. Source water found to contain E. coli is not considered water of
a safe, sanitary quality and would be unsuitable for bottled water
production. Before a bottler may use source water from a source that
has tested positive for E. coli, a bottler must take appropriate
measures to rectify or otherwise eliminate the cause of the
contamination. A source previously found to contain E. coli will be
considered negative for E. coli after five samples collected over a 24-
hour period from the same sampling site are tested and found to be E.
coli negative.
Description of Respondents: The respondents to this information
collection are domestic and foreign bottled water manufacturers that
sell bottled water in the United States.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden 1
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Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Sec. Sec. 129.35(a)(3)(i) and 129.80(h); 319 6 1,914 0.08 (5 minutes)......................... 153
bottlers subject to both source water and
finished product testing.
Sec. 129.80(g) and (h); bottlers only 95 3 285 0.08 (5 minutes)......................... 23
subject to finished product testing.
Sec. Sec. 129.35(a)(3)(i) and 129.80(h); 3 5 15 0.08 (5 minutes)......................... 1
bottlers conducting secondary testing of
source water.
Sec. Sec. 129.35(a)(3)(i) and 129.80(h); 3 3 9 0.25 (15 minutes)........................ 2
bottlers rectifying contamination.
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Total.................................... .............. .............. .............. ......................................... 179
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
The current CGMP regulations already reflect the time and
associated recordkeeping costs for those bottlers that are required to
conduct microbiological testing of their source water, as well as total
coliform testing of their finished bottled water products. We therefore
conclude that any additional burden and costs in recordkeeping based on
followup testing that is required if any coliform organisms detected in
the source water test positive for E. coli are negligible.
Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23741 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P
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